Pharmacovigilance Specialist Job Listing at Kelly Services in Bridgewater, NJ (Job ID 9444917)

Description

Pharmacovigilance Specialist 

Kelly® Science & Clinical is seeking a Pharmacovigilance Specialist 
 for our top clients in Bridgewater, NJ. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. 


Schedule: Hybrid 2 non consecutive days on site at the client 
Monday through Friday standard business hours
Length of assignment: Until Feb 2025
Responsible for post marketing and clinical safety activities, ensuring that Adverse Events are identified and processed in accordance with international regulations. Work in close collaboration with Company's vendors and affiliates to ensure that individual case reports for pre- and post-marketed products are properly produced, exchanged, and submitted. The Pharmacovigilance Specialist will be responsible for the medical assessment of adverse events cases; performance and maintenance of adverse event case review. 
Responsibilities:
•    Involved in signal detection activities and notifying Risk management per guidance
•    Support the team for any PV audit or inspection.
•    Provide coordination and support for the internal PV activities for local PV activities. 
•    Provide support in establishing/maintaining PV system.
•    Responsible for ensuring compliance with applicable Regulations and Corporate policies local and global . 
•    Provides oversight and support for external safety data processing provider ensuring high quality and compliant case processing.
•    Review and approve adverse event reports for pre- and post-marketed product: clarify medical issues, ensure clear narratives, revise MedDRA terms and coordinate with external vendor and internal medical personnel as needed. 
•    Support the team preparation for any PV audit or inspection.
•    Ensure compliance with regulations, all SOPs and partner agreements.
•    Review of Clinical trial protocols Phase I Phase III to ensure consistent and proper recording and processing of trial related AEs and SAEs.
•    Assist with creation of Analysis of Similar events and Investigator notification letters for IND Safety reports generated from company sponsored clinical trials. 
•    Analyze metrics for critical Drug Safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed. 
•    Represent the Pharmacovigilance department in interactions with key internal departments including Regulatory affairs, clinical R D, Medical and Quality Assurance and Medical communications. Review IND Annual and Periodic ADE reports; identify potential safety trends or signals; ensure accuracy and timely submission.
•    Inform manager and GPRM of safety related issues and potential trends and or signals arising from review of pre- and post-marketed safety data; recommend changes to labelling and Clinical Trial Investigator Brochure as needed.
•    Participate in review of SDEA and PV agreements with business partners, ensuring that company standards are upheld and international safety regulations are met.
•    Interact with compliance team to ensure necessary corrective and preventive actions have been taken to ensure compliance of pre- and post-marketing case processing.
•    Participate in creation and implementation of PV SOPs as needed. Maintain the internal and external correspondence within the defined duties and activities and ensures relevant archiving of PV documentation if needed. 
•    Oversight of Local PV vendor and US PV Support labeling update activities, maintenance of Reference Safety Information 
Requirements: 
•    Two to five years of Pharmacovigilance experience
•    Clinical safety and Pharmacovigilance regulations and guidelines. 
•    Use of safety database, preferably ARISg.
•    Understanding of local and International Pharmacovigilance regulations including GVP, GMP and ISO requirements
•    Excellent oral and written communication skills; excellent interpersonal skills and willingness to work in a team environment.
•    Demonstrates consistent attention to detail; highly organized and demonstrates understanding of workflow prioritization.

•    Education: 
•    BS or MS degree in Nursing, Pharmacy or related discipline or comparable field
What happens next?
Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry—even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what's next in your career is what we're all about,
#P1


 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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